FDA.reportPublic FDA data

MAUDE MDR 1024176

MDR report key
1024176
Report number
2083544-2008-00001
Event key
0
Event type
3
Date of event
2008-02-22
Date received
2008-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
HOWARD CHILDERS
Address
1750 WEST 214TH ST. TORRANCE CA 90501 US
Phone
310-310-3107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TISSUE-TEK PARAFORM BIOPSY CASSETTEIDZ, IDWSAKURA FINETEK U.S.A., INC.IDZ70197019R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-03-2601. O

Event Narratives#

D

Patient 1

PARAFORM CASSETTE CONTAINING PT BIOPSY WAS REPORTED AS POSSIBLY MISHANDLED DURING PROCESSING ON AUTOTEC DEVICE. CASSETTE WAS REPORTED AS SEPARATED FROM FRAME DURING PROCESSING AND WHEN FOUND DID NOT CONTAIN BIOPSY SPECIMEN. TECH SUPPORT PROVIDED ASSISTANCE WITH IDENTIFYING POSSIBLE AREAS INSIDE THE DEVICE FOR LOCATING CASSETTE/SPECIMEN. SERVICE WAS IMMEDIATELY DISPATCHED TO EVALUATE THE EVENT, ASSIST WITH LOCATING THE LOST CASSETTE, AND SERVICE THE DEVICE IF NECESSARY. USERS OF THE DEVICE REPORTED TO SERVICE THAT THEY DID NOT KNOW WHERE THE "MISSING" CASSETTE WAS. NO SURE IF THE CASSETTE WAS FOUND, SERVICE PERFORMED A THOROUGH EXAMINATION OF THE DEVICE AND DID NOT FIND ANY LOOSE CASSETTE. THE DEVICE WAS IN A READY FOR USE CONDITION. SERVICE RAN SEVERAL TEST CASSETTES ON THE DEVICE WITHOUT ERRORS OR FAILURE. CUSTOMER THEN RAN REGULAR WORK LOAD THROUGH THE DEVICE WITHOUT ERROR OR FAILURE. LATER, IT WAS REPORTED BY CUSTOMER PERSONNEL THAT THE MISSING CASSETTE WAS LOCATED ON THE DATE OF THE EVENT, BUT WAS FOUND TO BE MISSING THE SPECIMEN IT CONTAINED. CUSTOMER REPORTED CONDUCTING A THOROUGH SEARCH IN AND AROUND THE DEVICE, BUT COULD NOT LOCATE THE SPECIMEN.

N

Patient 1

DURING ON-SITE SERVICE CALL, SAKURA SERVICE TECH OBSERVED USER INCORRECTLY LOADING PARAFORM ASSEMBLY (CASSETTE AND FRAME) INTO AUTOTEC DELIVERY MAGAZINE. INCORRECT LOADING OF PARAFORM ASSEMBLY TO INPUT MAGAZINE CAN RESULT IN PARAFORM ASSEMBLY SEPARATION DURING PROCESSING BY THE AUTOTEC.